Magellan Robotic System recall
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Why was Magellan Robotic System recalled?
Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop when equipment button is released.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers.
- Product
- Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
- Recalling firm
- Hansen Medical Inc
- Quantity
- 19 total installed systems
- Distribution
- Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
- Recall date
- April 22, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)